Recall Z-1652-2008 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Incorporated
Ultraview Digital Telemetry Transmitter, Model 90478 The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, including asystole, ventricular fibrillation and ventricular tachycardia.
| Date | Sep 18, 2008 (initiated Jul 18, 2008) |
| Status | Terminated |
| Reason | Telemetry Modules are failing to alarm for low heart rate and asystole. |
| Root cause | Software design |
| Action | On 07/18/08 Spacelabs Healthcare issued a "URGENT-MEDICAL DEVICE CORRECTION" letter, dated July 16, 2008, to all customers who received the Spacelabs Medical Telemetry Receiver-Model 90478. The letter states circumstances in which the alarm fails, how to test each module for high rate alarm prior to patient use and a temporary work around if the alarm failure exists.` Letters have a receipt acknowledgement to ensure each customer receives the letter. Spacelabs Technical Support will personally install the new software, version V3.05.07EN, in all Spacelabs Medical Telemetry Receivers Model |
| Quantity | 37,590 |
| Distribution | Nationwide and Internationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925510 | MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING Spacelabs Medical, Inc., Oct 27, 1994 |